MITRAL-VALVE REPLACEMENT - RANDOMIZED TRIAL OF ST-JUDE AND MEDTRONIC-HALL PROSTHESES

To better define the merits of the bileaflet and tilting-disc valves, we prospectively randomized 102 patients (mean age, 57 years; range, 11 to 85 years) to receive either the St. Jude (n = 55) or the Medtronic-Hall (n = 47) mitral valve prosthesis between September 1986 and May 1991. The two groups were not different with respect to preoperative New York Heart Association class, incidence of mitral stenosis and insufficiency, angina score, extent of coronary artery disease, ventricular function, completeness of revascularization, or cross-clamp or bypass time. The hospital mortality (14.5% versus 10.6%, St. Jude versus Medtronic-Hall) and late mortality (7.3% versus 2.1%) were not significantly different. Follow-up was complete in 84 of 89 hospital survivors (94%) with a mean of 26 months (range, 1 to 60 months). The linearized rates of valve-related events and the 3-year actuarial survival demonstrated no significant differences between both cohorts. Comparison of the clinical outcome and echocardiographic parameters obtained at the time of follow-up demonstrated no significant differences between the two prostheses. These data indicate that the Medtronic-Hall and St. Jude mitral prostheses are similar with respect to their rates of valve-related complications and hemodynamic profiles. This study suggests that there is no difference between the St. Jude and Medtronic-Hall prostheses with regard to early clinical performance or hemodynamic results and therefore does not support the preferential selection of either prosthesis.